Food and Drug Administration

Food and Drug Administration

(FDA), agency of the Public Health Service division of the U.S. Department of Health and Human Services. It is charged with protecting public health by ensuring that foods are safe and pure, cosmetics and other chemical substances harmless, and products safe, effective, and honestly labeled. The Food, Drug, and Cosmetic Act of 1938 and various bills since have strengthened government control by requiring prior-evidence-of-safety tests and procedures for new drugs, pesticides, and additives and colorings in foods and cosmetics. The FDA was first established in 1931; in 1940 it was transferred from the Dept. of Agriculture to the Federal Security Agency and in 1953 to the Dept. of Health, Education and Welfare, which was redesignated as Health and Human Services in 1979. The FDA consists of the centers for Drug Evaluation and Research, Biologics Evaluation and Research, Food Safety and Applied Nutrition, Veterinary Medicine, Devices and Radiological Health, and Toxicological Research. In the early 1990s, in response to criticism that its time-consuming approval processes penalized people with AIDS, it extended the classification system it uses to prioritize drugs in order to give AIDS drugs the highest priority; it also subsequently sped up the approval process for cancer drugs. Congressional legislation in 1997 mandated an overhaul of the FDA in order to speed review of new drugs and medical devices.

Bibliography

See P. J. Hilt, Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation (2003) and D. Carpenter, Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA (2010).

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